The majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD.
According to a research letter, most of the melatonin gummy products assessed were inaccurately labeled, with the actual quantity of melatonin ranging from 74% - 347% of the labeled quantity. Only 12% of the products contained a quantity of melatonin that was within ±10% of the declared quantity.1
The recent study aimed to assess the actual quantity of melatonin and cannabidiol (CBD) in melatonin gummy products sold in the US compared with the quantities declared on the labels.
From 2012 - 2021, there was a 530% surge in pediatric melatonin ingestion reports to US Poison Control Centers, leading to 27,795 emergency department and clinic visits, 4,097 hospitalizations, 287 intensive care unit admissions, and 2 fatalities. 2
As a hormone produced naturally by the pineal gland in the brain, melatonin regulates the sleep-wake cycle. It is available over the counter as a dietary supplement or food and is commonly used for sleep, stress, and relaxation in both adults and children.
However, the efficacy of melatonin for these indications in healthy children is not supported by high-quality evidence. Despite this lack of evidence, the use of melatonin has increased during the COVID-19 pandemic, particularly among children.
The letter stated that inaccurate labeling of melatonin gummy products can lead to unintended exposure to unpredictable quantities of melatonin and CBD, especially in children. Melatonin doses as low as 0.1 - 0.3 mg can increase plasma concentrations into the normal nighttime range for young adults.
Children consuming melatonin gummies as directed could be exposed to between 40 and 130 times higher quantities of melatonin. Unintentional ingestions could lead to consumption that greatly exceeds these dosages of melatonin.
Investigators led by Pieter Cohen, MD, of Cambridge Health Alliance in Somerville Massachusetts, found inaccurate labeling on the majority of the melatonin gummy products. When compared with the labeled quantity, the actual quantity of melatonin showed a wide range, from 74% - 347% of what was labeled.
Just 12% of products included in the investigation contained a melatonin quantity within ±10% of the declared quantity. One product did not contain detectable levels of melatonin but did contain 31.3 mg of CBD, investigators reported.
In products that declared CBD as an ingredient, the actual quantity of CBD ranged from 104% - 118% of the labeled quantity. Serotonin, a potential contaminant, was not detected in any of the products.
Some limitations were noted, including a small sample size, only one sample of each brand analyzed, and only gummies were analyzed. It is not known if the results are generalizable to melatonin products sold as tablets and capsules in the US, or if the quantity of melatonin within an individual brand may also vary from batch to batch, according to the report.
Investigators recommended that clinicians should advise parents of the use of melatonin gummies because it may result in the ingestion of unpredictable quantities of melatonin and CBD. In addition to that, the efficacy of melatonin for sleep, stress, and relaxation in healthy children is not supported by high-quality evidence.
The use of melatonin products in children should be done under the supervision of a healthcare provider, the team wrote, and parents should ensure that the product they are using is from a reputable source and accurately labeled. The FDA does not approve melatonin products, which are sold as dietary supplements or food